Double Blinded, Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder

NCT00632229 | Completed Phase 2 Results

• 1 other identifier: USF 08-0100
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

Obsessive-compulsive disorder (OCD) is a common, chronic, and oftentimes disabling disorder. The only established treatments for OCD are a specific form of Cognitive Behavioral Therapy (CBT) and the Serotonin Reuptake Inhibitor medications (SRIs). Few patients with OCD experience complete symptom resolution with either modality and even after two consecutive SRI trials, as many as 30%-40% of patients fail to derive a satisfactory response. Pharmacological options for these SRI-resistant cases include switching to a different antidepressant, increasing the dose of SRI, or augmentation with another agent. Previous studies showed that approximately 33-50% of OCD patients who have not had an adequate response to SRI medication had a positive response when an atypical antipsychotic medication was added. However, the problematic acute and long-term side effects of these medications are of concern and, at times, limit their use. Paliperidone has a number of advantages over these medications including fewer drug interactions and better tolerability. Thus, this study is designed to determine whether paliperidone augmentation of an existing medication is effective relative to taking a placebo and your existing medication.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; Adults; Medication; Treatment

Outcome Measures

Primary Outcomes (1)

• Yale Brown Obsessive Compulsive Scale

  This measure assesses obsessive-compulsive symptom severity across 10 items that are completed during an interview format with the person with OCD. These 10 items are summed to derive a total score, which ranges from 0-40 \[Scale range: 0 (Minimum) - 40 (Maximum)\] with higher scores corresponding to more severe obsessive-compulsive symptoms.

  End of study (8 weeks)

Secondary Outcomes (1)

• Clinical Global Impressions - Severity of Obsessive-Compulsive Symptoms

  post-treatment

Study Arms (2)

Paliperidone

EXPERIMENTAL

Recieves study medication called paliperidone

Drug: Paliperidone

Pill placebo

PLACEBO COMPARATOR

Placebo comparator

Drug: Placebo

Interventions

Paliperidone DRUG

Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.

Also known as: Invega

Paliperidone

Placebo DRUG

Pill placebo taken daily ranging from 3-9mg/day depending on tolerability and efficacy.

Pill placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets DSM-IV-TR criteria for a principal current diagnosis of OCD which is confirmed by both clinical evaluation and by structured interviews. OCD subjects with other comorbidities will be included provided OCD is judged to be the chief complaint.
• Subjects must continue to experience clinically significant symptoms of OCD (Y-BOCS score ≥19 and a rating of "moderate" or greater on the Clinical Global Impressions (CGI) scale) despite at least two adequate SRI monotherapy trials. One unsatisfactory trial can include the SRI currently being taken by the patient provided that the duration of treatment is 12 weeks or more and that the dose has been adequate. Subjects must be taking a clinically effective dose of a SRI (i.e., clomipramine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) for at least 12 weeks. Subjects must be on their current dose for at least 12 weeks and must maintain their current dose throughout the study.
• Between the ages of 18-70 years of age.
• Only subjects with OC symptoms of at least one-year duration will be included.
• Eligible subjects must be in good physical health. Screening procedures will include detailed medical history, complete physical and neurological exams, routine blood studies (CBC, liver function tests, electrolytes), ECG, urine toxicology screen, and serum pregnancy test in women of child-bearing potential.

You may not qualify if:

• Primary depression, schizophrenia or other psychotic disorders.
• Active bipolar disorder.
• Non-responder in the past to atypical antipsychotic augmentation. This criterion was chosen to prevent recruiting a sample of chronically refractory OCD cases that would otherwise be suited for more extreme interventions such as deep brain stimulation.
• Non-responder in the past to an adequate trial (\> 20 hours) of cognitive-behavioral therapy that will be assessed by records review.
• Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention.
• Alcohol or other significant substance abuse within the last 6 months.
• History of neurosurgery, encephalitis or significant head trauma or a significant medical condition such as heart, liver, or renal disease.
• Nursing mothers or women of childbearing potential who do not use adequate contraception will be excluded.
• Subjects at an increased risk for seizures will also be excluded from this study (e.g., subjects with a history of seizures \[other than childhood febrile seizures\], subjects taking concomitant medications known to lower the seizure threshold).
• Estimated IQ \< 80, mental retardation, dementia, brain damage, or other cognitive impairment that would interfere with the capacity to participate in the study and complete measures. If needed, the WASI will be used to assess this at screening.
• Concurrent use of benzodiazepines, other than for treatment of insomnia, will be prohibited during the trial. No other psychotropic medications will be permitted.

Sponsors & Collaborators

• University of South Florida: lead
• Indiana University: collaborator
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (2)

University of South Florida

St. Petersburg, Florida, 33701, United States

Location

University Hospital Outpatient Center, Psychiatry

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Storch EA, Goddard AW, Grant JE, De Nadai AS, Goodman WK, Mutch PJ, Medlock C, Odlaug B, McDougle CJ, Murphy TK. Double-blind, placebo-controlled, pilot trial of paliperidone augmentation in serotonin reuptake inhibitor-resistant obsessive-compulsive disorder. J Clin Psychiatry. 2013 Jun;74(6):e527-32. doi: 10.4088/JCP.12m08278.

  PMID: 23842022 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

Modest sample and analyses were potentially underpowered to detect between-group differences on OCD measures. It was not possible to determine response from participants' current medication. Little racial/ethnic and socioeconomic variability

Results Point of Contact

• Title: Dr. Eric Storch
• Organization: University of South Florida

estorch@health.usf.edu

727-767-8230

Study Officials

• Eric A Storch, Ph.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 10, 2008
• Study Start: October 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 6, 2014
• Results First Posted: February 6, 2014

Record last verified: 2013-10

Locations

US (2)